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marzan

12/02/21 3:37 PM

#423457 RE: exwannabe #423454

if the BLAs are involved meeting the new endpoints, they won't announce any route they chose to apply, imo, just not to put FDA under stress, imo. See the shorts want to know everything upfront so that they can short even more, but no no with LP I guess.

Dr Bala

12/02/21 3:41 PM

#423458 RE: exwannabe #423454

Nonsensical speculation.

antihama

12/02/21 10:19 PM

#423537 RE: exwannabe #423454

I don't agree w your last statement

The fact that NWBO has not yet announced they have for Fast-Track, BreakThrough Designation or RMAT should be a red flag. Why do they not yet have that when all could have been obtained years ago if there is not some undisclosed elephant?

They need to have TLD first so that the regulatory authorities can make a determination if something like BTD could be considered. They're not going to make a determination based on several year old blinded data.